UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051194 |
|---|---|
| Receipt number | R000058387 |
| Scientific Title | Effect of virtual reality (VR) technology and physiotherapy on kinesiophobia in patients with chronic pain |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/05/30 06:09:03 |
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Basic information
Public title
Effect of virtual reality (VR) technology and physiotherapy on kinesiophobia in patients with chronic pain
Acronym
Effect of virtual reality (VR) technology and physiotherapy on kinesiophobia in patients with chronic pain
Scientific Title
Effect of virtual reality (VR) technology and physiotherapy on kinesiophobia in patients with chronic pain
Scientific Title:Acronym
Effect of virtual reality (VR) technology and physiotherapy on kinesiophobia in patients with chronic pain
Region
| Japan |
Condition
Condition
patients with chronic pain
Classification by specialty
| Surgery in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effect of virtual reality (VR) technology and physiotherapy on kinesiophobia in patients with chronic pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kinesiophobia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
virtual reality (VR) technology and physiotherapy
Interventions/Control_2
physiotherapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic pain for more than 3 months
age 18to 75 years
worker
Key exclusion criteria
acute pain such as trauma
severe cognitive
inability to provide informed consent
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Sakuma |
Organization
Graduated School of Rehabilitation Sciences, Seirei Christopher University
Division name
Rehabilitation Sciences
Zip code
433-8558
Address
3453 Mikatahara-cho, Kita-ku, Hamamatsu City, Shizuoka Prefecture
TEL
09085504006
20dr03@g.seirei.ac.jp
Public contact
Name of contact person
| 1st name | shunsuke |
| Middle name | |
| Last name | sakuma |
Organization
Graduated School of Rehabilitation Sciences, Seirei Christopher University
Division name
Rehabilitation Sciences
Zip code
433-8558
Address
3453 Mikatahara-cho, Kita-ku, Hamamatsu City, Shizuoka Prefecture
TEL
09085504006
Homepage URL
20dr03@g.seirei.ac.jp
Sponsor or person
Institute
Graduated School of Rehabilitation Sciences, Seirei Christopher University
Institute
Department
Personal name
Funding Source
Organization
Graduated School of Rehabilitation Sciences, Seirei Christopher University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduated School of Rehabilitation Sciences, Seirei Christopher University
Address
3453 Mikatahara-cho, Kita-ku, Hamamatsu City, Shizuoka Prefecture
Tel
09085504006
20dr03@g.seirei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
70
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 30 | Day |
Last modified on
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058387
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
